510(k) · Cleared
ClearedThe Cranial Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · NKG Posterior Cervical Screw System
Cleared on May 1, 2017 as substantially equivalent to K161591 (Globus Medical, Inc., 2016) and 4 other predicates after a 263-day review. Its family tree reaches back 18 generations to 2004. 1 later device descends from it.
- Decided
- May 1, 2017
- Review
- 263 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K040583 (2004). 336 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations between
- 3 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- 1 generation backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- This deviceK162266 The Cranial Fusion SystemLife Spine, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK200896 Solstice CCILife Spine, Inc. · 2020
Show all 18 generations
- Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 5 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 4 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 3 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 2 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- 1 generation backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- This deviceK162266 The Cranial Fusion SystemLife Spine, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K200896Solstice CCILife Spine, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −15 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −13 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −11 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −10 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −9 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −8 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −7 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −6 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −5 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −4 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −3 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −2 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −1 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| 0 (this device) | K162266 | The Cranial Fusion System | Life Spine, Inc. | 2017 | — |
| +1 | K200896 | Solstice CCI | Life Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 11 | 0 |
| 1996 | 6 | 0 |
| 1997 | 11 | 0 |
| 1998 | 12 | 0 |
| 1999 | 10 | 0 |
| 2000 | 17 | 0 |
| 2001 | 25 | 0 |
| 2002 | 19 | 0 |
| 2003 | 19 | 0 |
| 2004 | 38 | 0 |
| 2005 | 29 | 0 |
| 2006 | 21 | 0 |
| 2007 | 14 | 0 |
| 2008 | 21 | 0 |
| 2009 | 15 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments Cleared while this submission was under review Summary page 4…Unclassified Product Codes: NKG, KWP Primary Predicate: The Globus QUARTEX Occipito-Cervico-Thoracic Spinal System (K161591) Additional Predicate: Solstice OCT System (K142253) The Sentinel Spinal System (K090343)… | 2016 |
| * | K142253 | SOLSTICE OCT SystemSummary page 4…y Predicate: The Globus QUARTEX Occipito-Cervico-Thoracic Spinal System (K161591) Additional Predicate: Solstice OCT System (K142253) The Sentinel Spinal System (K090343) The Solanas Avalon Posterior Fixati… | 2015 |
| * | K090343 | Sentinel Spinal SystemSummary page 4…c Spinal System (K161591) Additional Predicate: Solstice OCT System (K142253) The Sentinel Spinal System (K090343) The Solanas Avalon Posterior Fixation System (K111076) The Gibralt Occip… | 2009 |
| * | K111076 | Solanas Avalon Posterior Fixation SystemSummary page 4…Solstice OCT System (K142253) The Sentinel Spinal System (K090343) The Solanas Avalon Posterior Fixation System (K111076) The Gibralt Occipital Spine System (K160697) Device Description: The Cranial Fusion System is a t… | 2011 |
| * | K160697 | Gibralt® Spine System and Gibralt® Occipital Spine SystemSummary page 4…pinal System (K090343) The Solanas Avalon Posterior Fixation System (K111076) The Gibralt Occipital Spine System (K160697) Device Description: The Cranial Fusion System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200896 | Solstice CCI | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 33 of the 336 ancestors have a recall of any class.
- Of its descendants, K200896 (Life Spine, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K161591.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The Cranial Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and…
Read the full statement (167 words)
The Cranial Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to
fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the
thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous
fusions (e.g., pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including
intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic
studies, and degenerative disease of the facets with instability.
The Cranial Fusion System is also intended to restore the integrity of the spinal column even in the absence of fusion for a
limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of
insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, The Cranial Fusion System may be connected to the titanium Life Spine
NAUTILUS Spine System using the 3.5mm/5.5mm titanium parallel connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162266: The Cranial Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162266
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026